Reported Reactions

Adverse event reports that FDA received

  • Search
  • Watch list

Haemorrhoids adverse event reports that record this term

Kind of term
MedDRA preferred term

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From January 2004 to June 2026, FDA received 19,167 adverse event reports that record the MedDRA preferred term Haemorrhoids. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 906 reports in the 12 months to June 2026 and 917 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 652 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 906 (0.1%) record this term. Reports for patients aged 45 to 64 were 25.4% of the reports that record this term and 20% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 113 drug pages with 50 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Drugs that the reports with the term Haemorrhoids name as a suspect product, in order of name
DrugClassReports with this term
AccutaneRetinoid388
ActemraInterleukin-6 receptor antagonist97
AfinitorKinase inhibitor57
Albuterol sulfatebeta2-Adrenergic agonist56
Alendronate sodiumBisphosphonate174
AmlodipineCalcium channel blocker73
ApixabanFactor Xa inhibitor110
Aredia150
AspirinNonsteroidal anti-inflammatory drug208
AvastinVascular endothelial growth factor inhibitor110
AvonexInterferon beta63
AzorAngiotensin 2 receptor blocker132
BenicarAngiotensin 2 receptor blocker1,306
Benicar HCTThiazide diuretic965
BevacizumabVascular endothelial growth factor inhibitor70
Bisoprololbeta-Adrenergic blocker53
Boniva67
CabometyxKinase inhibitor107
CapecitabineNucleoside metabolic inhibitor51
CarboplatinPlatinum-based drug76
Cholecalciferol50
Copegus105
CosentyxInterleukin-17A antagonist145
Coumadin63
CyclophosphamideAlkylating drug132
Cymbalta80
DexamethasoneCorticosteroid93
DigoxinCardiac glycoside64
DiovanAngiotensin 2 receptor blocker56
Doxorubicin hydrochlorideAnthracycline topoisomerase inhibitor68
DupixentInterleukin-4 receptor alpha antagonist54
EliquisFactor Xa inhibitor202
EnbrelTumor necrosis factor blocker261
EntrestoAngiotensin 2 receptor blocker60
EntyvioIntegrin receptor antagonist75
FluorouracilNucleoside metabolic inhibitor66
ForteoParathyroid hormone analog103
FosamaxBisphosphonate574
Fosamax Plus D119
FurosemideLoop diuretic62
GabapentinAnti-epileptic agent66
Humira1,167
IbranceKinase inhibitor89
IbuprofenNonsteroidal anti-inflammatory drug58
IfosfamideAlkylating drug54
ImbruvicaKinase inhibitor87
Incivek690
Incivo86
InflectraTumor necrosis factor blocker210
InfliximabTumor necrosis factor blocker200
Iron51
JanuviaDipeptidyl peptidase 4 inhibitor51
KisqaliKinase inhibitor83
LansoprazoleProton pump inhibitor58
LetrozoleAromatase inhibitor59
LinzessGuanylate Cyclase-C agonist51
LipitorHMG-CoA reductase inhibitor94
MetforminBiguanide68
MethotrexateFolate analog metabolic inhibitor233
Methotrexate sodiumFolate analog metabolic inhibitor59
Morphine sulfateOpioid agonist84
NexiumProton pump inhibitor108
NuvaringEstrogen61
OfevKinase inhibitor128
OpsumitEndothelin receptor antagonist65
OrenciaSelective T cell costimulation modulator52
OtezlaPhosphodiesterase 4 inhibitor62
Oxycodone hydrochlorideOpioid agonist74
OxyContinOpioid agonist71
PaclitaxelMicrotubule inhibitor58
PantoprazoleProton pump inhibitor62
Pantoprazole sodiumProton pump inhibitor64
PegasysInterferon alpha618
Peginterferon Alfa-2b74
Pegintron50
PlavixP2Y12 platelet inhibitor76
PradaxaDirect thrombin inhibitor206
PrednisoloneCorticosteroid51
PrednisoneCorticosteroid217
Propecia5-alpha reductase inhibitor71
RemicadeTumor necrosis factor blocker203
RevlimidThalidomide analog249
Ribasphere66
RibavirinNucleoside analog antiviral619
RinvoqJanus kinase inhibitor104
RituximabCD20-directed cytolytic antibody124
RivaroxabanFactor Xa inhibitor57
SandostatinSomatostatin analog62
Sandostatin LAR Depot120
SeroquelAtypical antipsychotic73
SkyriziInterleukin-23 antagonist116
StelaraInterleukin-12 antagonist64
SutentKinase inhibitor113
Synthroidl-Thyroxine51
TacrolimusCalcineurin inhibitor immunosuppressant83
TasignaKinase inhibitor61
Tecfidera56
Telaprevir160
TrastuzumabHER2/neu receptor antagonist77
TribenzorThiazide diuretic75
TysabriIntegrin receptor antagonist72
ValsartanAngiotensin 2 receptor blocker80
VedolizumabIntegrin receptor antagonist619
VenclextaBCL-2 inhibitor59
VenetoclaxBCL-2 inhibitor67
Vioxx292
Vx-950341
WarfarinVitamin K antagonist54
Warfarin sodiumVitamin K antagonist56
XareltoFactor Xa inhibitor221
XeljanzJanus kinase inhibitor177
XyremCentral nervous system depressant74
Zometa249

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 51 pharmacologic classes with 100 or more reports that record this term. The rows are in order of name.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.

Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of . The site read the page on .

Pharmacologic classes of the drugs that the reports with the term Haemorrhoids name, in order of name
ClassReports with this term
5-alpha reductase inhibitor113
Alkylating drug208
alpha-Adrenergic blocker104
Aminosalicylate111
Angiotensin 2 receptor blocker1,782
Anthracycline topoisomerase inhibitor135
Antimetabolite immunosuppressant106
Aromatase inhibitor131
Atypical antipsychotic194
BCL-2 inhibitor126
beta-Adrenergic blocker115
Biguanide111
Bisphosphonate825
Calcineurin inhibitor immunosuppressant171
CD20-directed cytolytic antibody199
Corticosteroid586
Direct thrombin inhibitor212
Endothelin receptor antagonist169
Estrogen112
Factor Xa inhibitor598
Folate analog metabolic inhibitor292
GLP-1 receptor agonist210
HER2/neu receptor antagonist194
HMG-CoA reductase inhibitor264
Integrin receptor antagonist766
Interferon alpha632
Interferon beta113
Interleukin-17A antagonist159
Interleukin-23 antagonist119
Interleukin-6 receptor antagonist119
Janus kinase inhibitor329
Kinase inhibitor1,133
Loop diuretic103
Microtubule inhibitor108
Nonsteroidal anti-inflammatory drug488
Nucleoside analog antiviral622
Nucleoside metabolic inhibitor225
Opioid agonist590
Osmotic laxative157
P2Y12 platelet inhibitor134
Parathyroid hormone analog113
Platinum-based drug138
Programmed death Receptor-1 blocking antibody131
Prostacycline vasodilator138
Proton pump inhibitor425
Retinoid428
Thalidomide analog322
Thiazide diuretic1,058
Tumor necrosis factor blocker1,120
Vascular endothelial growth factor inhibitor192
Vitamin K antagonist110

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Haemorrhoids, by month, five years to June 2026
010020020222023202420252026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Patients in these reports

Age of the patient in the reports that record Haemorrhoids
AgeReportsShareShare as a bar
Under 26under 0.1%
2 to 11120.1%
12 to 17860.4%
18 to 442,13511.1%
45 to 644,87625.4%
65 to 742,54113.3%
75 and over1,7869.3%
Age not given7,72540.3%
Sex of the patient in the reports that record Haemorrhoids
SexReportsShareShare as a bar
Female9,56749.9%
Male6,84235.7%
Unknown or not given2,75814.4%

Age and sex are as the report gives them. 63.3% of these reports give the United States as the country.

Terms near this one

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Haemorrhoids: adverse event reports that record this term. https://reportedreactions.com/reaction/haemorrhoids/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

The count has the reports with each spelling of one MedDRA preferred term. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

What does Haemorrhoids mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.

Source: openFDA, Drug Adverse Event Overview. The site read the page on .

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.

Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on .